Valves, devices, and methods for endobronchial therapy

• US 20070083677A1
• Filed: 05/18/2006
• Published: 04/12/2007
• Est. Priority Date: 05/18/2005
• Status: Abandoned Application

• Current Assignee: Nektar Therapeutics
• Original Assignee: Nektar Therapeutics
• Inventors: Alston, William, Smith, Adrian, Hall, Gregory, Cecka, Walter, Cohen, Gal, Fisher, Winfield
• Application Number:
  US11/436,239
• Publication Number:
  US 20070083677A1
• Time in Patent Office: Days
• US Class Current: 710/1
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/025 Bubble jet droplet ejection devices
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: F16K 1/18 with pivoted discs or flaps
• CPC Class Codes: F16K 15/14 with flexible valve members
• CPC Class Codes: F16K 15/148 the closure elements being fixed in their centre
• CPC Class Codes: Y10T 137/7891 Flap or reed

Abstract

Various valves, adapters, ventilator circuits, and methods are disclosed. In one or more embodiments, a valve includes a support that includes a plurality of apertures. The support includes a center and an outer edge. The plurality of flaps includes a flap for each aperture. Each flap has an end connected proximal to the center of the support. Each flap is capable of moving between a closed position and an opened position.

Claims

1. A valve, comprising:

a support comprising a plurality of apertures, the support comprising a center and an outer edge; and

at least one flap for each aperture, wherein said flap has an end connected proximal to the center of the support, said flap is capable of moving, by a fluid pressure differential between at least one of a closed position and an opened position and wherein the valve has an opening pressure of less than 50 cm H₂O.

2. The valve of claim 1, wherein the valve comprises a one-way valve.

3. The valve of claim 1, wherein the support comprises at least two apertures.

4. The valve of claim 1, wherein the support comprises at least four apertures.

5. The valve of claim 4 and further including at least four flaps .

6. The valve of claim 5, wherein the valve exhibits a flow pattern substantially as FIG. 20B.

7. The valve of claim 1, wherein each flap is biased in the closed position.

8. The valve of claim 1, wherein each flap is biased in the opened position.

9. The valve of claim 1, wherein each flap is biased in the closed position by a spring.

10. The valve of claim 1, wherein the support is circular.

11. The valve of claim 1 wherein at least one of said apertures has a side angle of about 0 degrees.

12. The valve of claim 1, wherein each flap comprises a moving end opposite to the connected end, the moving end contacting the outer edge of the support in the closed position.

13. The valve of claim 12, wherein the outer edge of the support comprises at least one protrusion that contacts the flap.

14. The valve of claim 13, wherein the at least one protrusion is triangular.

15. The valve of claim 1, wherein each of the plurality of flaps are integral with each other.

16. The valve of claim 1, wherein each of the plurality of flaps are integral with each other and comprise four lobes.

17. The valve of claim 1, wherein each of the plurality of flaps are distinct parts.

18. The valve of claim 1, wherein the support and each flap are integral with each other.

19. The valve of claim 1, wherein the support and each flap are distinct parts.

20. The valve of claim 1, wherein the flap comprises an elastomer having a Shore A hardness ranging from about 20 to about 90.

21. The valve of claim 1, wherein the support and each flap comprise a material having a creep resistance of less than about 1% elongation under a load of 800 psi at 23°

C. after 1000 hours.

22. The valve of claim 1, wherein each flap comprises a rigid material, and wherein each flap is connected to the support by a hinge.

23. The valve of claim 1, wherein the support comprises at least one member selected from polymer, metal, ceramic, and composite.

24. The valve of claim 1, wherein the support comprises an elastomer.

25. The valve of claim 1, wherein the support comprises at least one polymer.

26. The valve of claim 1, wherein the support comprises at least one polymer selected from polyurethane, fluoropolymer, silicone, and ethylene propylene diene monomer (EPDM).

27. The valve of claim 1, wherein each flap comprises at least one polymer.

28. The valve of claim 1, wherein each flap comprises at least one polymer selected from polyurethane, fluoropolymer, silicone, and ethylene propylene diene monomer (EPDM).

29. The valve of claim 1, wherein the support and each flap comprise at least one polymer.

30. The valve of claim 1, wherein the support and each flap comprise at least one polymer selected from polyurethane, fluoropolymer, silicone, and ethylene propylene diene monomer (EPDM).

31. The valve of claim 1, wherein the support and flap comprise a material selected from a reinforced material and a laminate.

32. The valve of claim 31, wherein the reinforced material comprises at least one member selected from particle reinforced material, fiber reinforced material, and composite material.

33. The valve of claim 32, wherein the reinforced material comprises silicone with a woven reinforcement.

34. The valve of claim 32, wherein the laminate material comprises parylene adhered to silicone, polytetrafluoroethylene coated polymer, polyimide coated polymer, reinforcement layer laminated on silicone, and a first silicone having a first durometer on a second silicone having a second durometer higher than the first durometer.

35. The valve of claim 1, wherein a pressure of less than about 5 cm H₂O causes the flap to pivot from the closed position to the opened position.

36. A valve, comprising:

a support comprising an aperture;

a flap connected to the support; and

at least one protrusion on at least one member selected from the support and the flap, wherein the at least one protrusion on at least one member selected from the support and the flap has a surface that contacts the other of the support and the flap when the flap is in a closed position, and wherein the valve has an opening pressure of less than 50 cm H₂O.

37. The valve of claim 36, wherein the surface of the flap has a total surface area and a contact surface area that is in contact with the at least one protrusion, the contact surface area being less than about 5% of the total surface area.

38. The valve of claim 36, wherein the surface of the flap has a total surface area and a contact surface area that is in contact with the at least one protrusion, the contact surface area being less than about 1% of the total surface area.

39. The valve of claim 36, wherein the surface of the flap has a total surface area and a contact surface area that is in contact with the at least one protrusion, the contact surface area being less than about 0.1% of the total surface area.

40. The valve of claim 36, wherein the surface of the flap has a total surface area and a contact surface area that is in contact with the at least one protrusion, the contact surface area being less than about 0.01% of the total surface area.

41. The valve of claim 36, wherein the flap comprises a connected end that is proximal to a center of the support.

42. The valve of claim 41, wherein the flap comprises a moving end opposite to a connected end, the moving end contacting an outer edge of the support in a closed position.

43. The valve of claim 42, wherein the outer edge of the support comprises the at least one protrusion that contacts the flap.

44. The valve of claim 43, wherein the at least one protrusion is triangular.

45. The valve of claim 36, wherein the flap comprises a connected end that is proximal to an outer edge of the support.

46. The valve of claim 45, wherein the flap comprises a moving end opposite to the connected end, the moving end contacting a center portion of the support in a closed position.

47. The valve of claim 46, wherein the center portion of the support comprises the at least one protrusion that contacts the flap.

48. The valve of claim 47, wherein the at least one protrusion is triangular.

49. A valve, comprising:

a support comprising an aperture;

a flap connected to the support, the flap having a surface contacting the support when the flap is in a closed position; and

at least one channel in at least one member selected from the support and the flap, the at least one channel allowing fluid flow through the valve when the flap is in the closed position.

50. The valve of claim 49, wherein the at least one channel is in at least the support.

51. The valve of claim 49, wherein the at least one channel is in at least the flap.

52. The valve of claim 49, wherein fluid flow through the valve when the flap is in an opened position is at least about 2 times greater than fluid flow through the valve when the flap is in the closed position.

53. The valve of claim 49, wherein fluid flow through the valve when the flap is in an opened position is at least about 10 times greater than fluid flow through the valve when the flap is in the closed position.

54. The valve of claim 49, wherein fluid flow through the valve when the flap is in an opened position is at least about 100 times greater than fluid flow through the valve when the flap is in the closed position.

55. An adapter, comprising:

a housing forming a first channel and a second channel, the housing having a first end and a second end;

the first channel comprising a first one-way valve to allow flow in a first direction and impair flow in a second direction;

the second channel comprising a second one-way valve to allow flow in a third direction and impair flow in a fourth direction; and

at least one of an aerosolization device and an aerosolization device port in the first channel positioned downstream, relative to the first direction, of the one-way valve, wherein an air pressure drop between the first end and the second end of the adapter is less than about 50 cm H₂O at an air flow rate of 60 L/min.

56. The adapter of claim 55, wherein the first and second one-way valves do not invert when air pressure changes in an amount of up to about 2 psi in less than 0.5 second.

57. The adapter of claim 55, wherein the air pressure drop ranges from about 0.05 cm H₂O to about 10 cm H₂O.

58. The adapter of claim 55, wherein the air pressure drop ranges from about 2 cm H₂O to about 4 cm H₂O.

59. An adapter, comprising:

a housing forming a first channel and a second channel, the housing having a first end and a second end;

the first channel comprising a first one-way valve to allow flow in a first direction and impair flow in a second direction;

the second channel comprising a second one-way valve to allow flow in a third direction and impair flow in a fourth direction;

at least one of an aerosolization device and an aerosolization device port in the first channel positioned downstream, relative to the first direction, of the one-way valve; and

a fluid accumulator in the second channel positioned upstream, relative to the third direction, of the second one-way valve.

60. The adapter of claim 59, wherein the fluid accumulator comprises a port.

61. The adapter of claim 60, wherein the port comprises a valve.

62. The adapter of claim 60, wherein the port comprises at least one member selected from a stop-cock, sphincter valve, injection site, and removable cap.

63. The adapter of claim 59, wherein the fluid accumulator comprises a reservoir formed in the second channel.

64. The adapter of claim 63, wherein the second channel has an oval cross-section.

65. An adapter, comprising:

a housing forming a first channel and a second channel, the housing having a first end and a second end;

the first channel comprising a first one-way valve to allow flow in a first direction and impair flow in a second direction;

the second channel comprising a second one-way valve to allow flow in a third direction and impair flow in a fourth direction;

at least one of an aerosolization device and an aerosolization device port in the first channel positioned downstream, relative to the first direction, of the one-way valve; and

a sensor probe port in the first channel positioned upstream, relative to the first direction, of the at least one of an aerosolization device and an aerosolization device port.

66. The adapter of claim 65, further comprising a sensor probe in the sensor probe port, the sensor selected form temperature sensors, flow sensors, pressure sensors and moisture sensors.

67. The adapter of claim 66, wherein the sensor probe comprises at least one member selected from resistance temperature detector, thermistor, and thermocouple.

68. A ventilator circuit, comprising:

an exhalation line adapted for connection to a ventilator;

an inhalation line adapted for connection to a ventilator;

an adapter connected to the exhalation line and the inhalation line, the adapter comprising at least one of a nebulizer and a nebulizer port; and

a Y-tube connected to the adapter; and

optionally, a tube selected from an endotracheal tube and a tracheostomy tube connected to the Y-tube.

69. The ventilator circuit of claim 68, wherein the Y-tube has a length of up to about 1 m.

70. The ventilator circuit of claim 68 and further including a valve, the valve comprising at least a support comprising a plurality of apertures, the support comprising a center and an outer edge;

and

at least one flap for each aperture, wherein said flap has an end connected proximal to the center of the support, said flap is capable of moving, by a fluid pressure differential between at least one of a closed position and an opened position and wherein the valve has an opening pressure of less than 50 cm H₂O.